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临床试验/NCT00469248
NCT00469248已完成不适用

Intra-Aortic Balloon Counterpulsation in Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock - The Prospective, Randomised IABP SHOCK Trial for Attenuation of Multi-Organ Dysfunction Syndrome

Martin-Luther-Universität Halle-Wittenberg2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2003年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
2
主要终点
APACHE II SCORE

研究概览

简要总结

The role of intra aortic balloon counterpulsation in patients experiencing acute myocardial infarction with shock is not established. We hypothesised that use of such a device would lead to improved outcomes in these patients.

详细描述

Patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) with cardiogenic shock (CS) are often treated with Intra-aortic balloon pump counterpulsation (IABP) although the evidence to support this is limited. We conducted a prospective, randomised clinical trial, of IABP as an addition to PCI centred therapy, in patients with AMI complicated by CS.

45 patients with AMI and CS undergoing PCI were randomised to care with or without IABP. Over 4 days, APACHE II scores, haemodynamic parameters, inflammatory markers and BNP levels were collected to assess the impact of IABP treatment on CS triggered multi organ dysfunction syndrome (MODS).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Acute myocardial infarction
  • Cardiogenic shock

排除标准

  • Absent peripheral pulses
  • Mechanical complications of myocardial infarction

结局指标

主要结局

APACHE II SCORE

时间窗: 4 days

次要结局

  • Haemodynamic state(4 days)
  • BNP levels(4 days)
  • Inflammatory activation(4 days)
  • Mortality(4 days)

研究者

申办方类型
Other

研究点 (2)

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